Notice2025-23852
Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 29, 2025
Effective
October 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR)s for fiscal years 2026 through 2030. In this notice, FDA is announcing the OMOR fee rates for fiscal year (FY) 2026. FDA plans to announce the FY 2026 OMUFA facility fee rates, i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of the OMUFA facility fee rate publication for prior FYs).
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60719-60721]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6896]
Over-the-Counter Monograph Drug User Fee Amendments--OTC
Monograph Order Request Fee Rates for Fiscal Year 2026
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Over-the-Counter Monograph Drug User Fee Amendments
(herein referred to as ``OMUFA II''), authorizes the Food and Drug
Administration (FDA, the Agency, or we) to assess and collect user fees
from qualifying manufacturers of over-the-counter (OTC) monograph drugs
and submitters of OTC monograph order requests (OMOR)s for fiscal years
2026 through 2030. In this notice, FDA is announcing the OMOR fee rates
for fiscal year (FY) 2026. FDA plans to announce the FY 2026 OMUFA
facility fee rates, i.e., monograph drug facility (MDF) and contract
manufacturing organization (CMO) facility fee rates, in a subsequent
Federal Register notice (and anticipates its issuance will generally
align with the timing of the OMUFA facility fee rate publication for
prior FYs).
DATES: These OMOR fees are effective on October 1, 2025, and will
remain in effect through September 30, 2026.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240-402-4989; or the User Fees Support
Staff at <a href="/cdn-cgi/l/email-protection#2d626200626b6f6c00626b6000786b7e7e006a425b485f43404843596d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="bef1f193f1f8fcff93f1f8f393ebf8eded93f9d1c8dbccd0d3dbd0cafed8dadf90d6d6cd90d9d1c8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 744M of the FD&C Act (21 U.S.C. 379j-72), as amended by
OMUFA II,\1\ authorizes FDA to assess and collect, for each of fiscal
years 2026 through 2030: (1) facility fees from qualifying owners of
OTC MDFs and (2) fees from submitters of qualifying OTC OMORs. These
fees are to support FDA's OTC monograph drug activities, which are
detailed in section 744L(6) of the FD&C Act (21 U.S.C. 379j-71(6)) and
include specified FDA activities associated with regulating OTC
monograph drugs.\2\
---------------------------------------------------------------------------
\1\ Over-the-Counter Monograph Drug User Fee Amendments, title V
of Division F of the Continuing Appropriations, Agriculture,
Legislative Branch, Military Construction and Veterans Affairs, and
Extensions Act, 2026 (Pub. L. 119-37).
\2\ For OMUFA purposes, an OTC monograph drug is a
nonprescription drug without an approved new drug application that
is governed by the provisions of section 505G of the FD&C Act (21
U.S.C. 355h) (see section 744L(5) of the FD&C Act).
---------------------------------------------------------------------------
For OMUFA purposes, an OMOR is a request for an administrative
order, with respect to an OTC monograph drug, which is submitted under
section 505G(b)(5) of the FD&C Act (see section 744L(7) of the FD&C
Act).
Under section 744M(a)(2)(A) of the FD&C Act, the Agency is
authorized to assess and collect fees from submitters of OMORs, except
for OMORs that request certain safety-related changes (as discussed
below). There are two levels of OMOR fees, based on whether the OMOR at
issue is a Tier 1 or Tier 2 OMOR.\2\
---------------------------------------------------------------------------
\2\ Under OMUFA, a Tier 1 OMOR is defined as any OMOR that is
not a Tier 2 OMOR (see section 744L(8) of the FD&C Act). Tier 2
OMORs are detailed in section 744L(9) of the FD&C Act.
---------------------------------------------------------------------------
For FY 2026, the OMUFA fee rates for OMORs are: Tier 1 OMOR fees
($587,529) and Tier 2 OMOR fees ($117,505). These fees are effective
for the period from October 1, 2025, through September 30, 2026. This
document is issued pursuant to section 744M(a)(2) and (c)(5) of the
FD&C Act and describes the calculations used to set the OMUFA OMOR fees
for FY 2026 in accordance with the directives in the statute.
II. Determination of FY 2026 OMOR Fees
For FY 2026, the Tier 1 OMOR fee is $587,529 and the Tier 2 OMOR
fee is $117,505, including an adjustment for inflation (see sections
744M(a)(2)(A)(i) and (ii) of the FD&C Act, respectively). OMOR fees are
not included in the OMUFA target revenue calculation, which is based on
the facility fees (see section 744M(b) of the FD&C Act).
An OMOR fee is generally assessed to each person who submits an
OMOR (see section 744M(a)(2)(A) of the FD&C Act). OMOR fees are due on
the date of the submission of the OMOR (see section 744M(a)(2)(B) of
the FD&C Act). The payor should submit the OMOR fee that applies to the
type of OMOR they are submitting (i.e., Tier 1 or Tier 2). FDA will
determine whether the appropriate OMOR fee has been submitted following
receipt of the OMOR and the fee.
An OMOR fee will not be assessed if the OMOR seeks to make certain
safety changes with respect to an OTC monograph drug. Specifically, no
fee will be assessed if FDA finds that the OMOR seeks to change the
drug facts labeling of an OTC monograph drug in a way that would add to
or strengthen: (1) a contraindication, warning, or precaution; (2) a
statement about risk associated with misuse or abuse; or (3) an
instruction about dosage and administration that is intended to
increase the safe use of the OTC monograph drug (see section
744M(a)(2)(C) of the FD&C Act).
III. OMOR Fee Adjustment for Inflation
The dollar amount of the inflation adjustment to the fee for OMORs
for FY 2026 is equal to the product of the applicable fee for FY 2025
and the inflation adjustment percentage.\3\ For FY 2026, the inflation
adjustment percentage is equal to the sum of:
---------------------------------------------------------------------------
\3\ See section 744M(c)(1)(B) of the FD&C Act.
---------------------------------------------------------------------------
<bullet> The average annual percent change in the cost, per full-
time equivalent (FTE) position at FDA, of all personnel compensation
and benefits (PC&B) paid with respect to such positions for the first 3
years of the preceding 4 FYs, multiplied by the proportion of PC&B
costs to total FDA costs of OTC monograph drug activities for the first
3 years of the preceding 4 FYs (see section 744M(c)(1)(C)(i) of the
FD&C Act); and
<bullet> The average annual percent change that occurred in the
Consumer Price Index (CPI) for urban consumers (Washington-Arlington-
Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4 years of available data
multiplied by the proportion of all costs other than PC&B costs to
total costs of OTC monograph drug activities for the first 3 years of
the preceding 4 FYs (see section 744M(c)(1)(C)(ii) of the FD&C Act).
Table 1 summarizes the actual cost and FTE data for the specified
FYs, provides the percent changes from the
[[Page 60720]]
previous FYs, and provides the average percent changes over the first 3
of the 4 FYs preceding FY 2026. The 3-year average is 5.4494 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $3,165,477,000 $3,436,513,000 $3,791,729,000 .................
Total FTEs.......................... 18,474 18,729 19,687 .................
PC&B per FTE........................ $171,348 $183,486 192,601 .................
Percent Change from Previous Year... 4.2967% 7.0838% 4.9677% 5.4494%
----------------------------------------------------------------------------------------------------------------
Under the statute, this 5.4494 percent is multiplied by the
proportion of PC&B costs to the total FDA costs of OTC monograph drug
activities for the first 3 years of the preceding 4 FYs (see section
744M(c)(1)(C)(i) of the FD&C Act).
Table 2 shows the PC&B and the total obligations for OTC monograph
drug activities for the first 3 of the preceding 4 FYs.
Table 2--PC&B as a Percent of Total Cost of OTC Monograph Drug Activities
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................................... $25,415,237 $39,133,075 $41,579,890 ................
Total Costs......................................... $49,644,273 $68,480,052 $68,176,240 ................
PC&B Percent........................................ 51.1947% 57.1452% 60.9888% 56.4429%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 5.4494 percent from table 1 multiplied by
56.4429 percent from table 2, resulting in 3.0758 percent.
Table 3 provides the summary data for the percent changes in the
specified CPI for the Washington-Arlington-Alexandria, DC-VA-MD-WV
area.\4\
---------------------------------------------------------------------------
\4\ The data are published by the Bureau of Labor Statistics on
its website: <a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria, DC-VA-MD-WV Area
----------------------------------------------------------------------------------------------------------------
Year 2022 2023 2024 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................................... 296.12 305.32 315.19 ................
Annual Percent Change........................................... 6.6212% 3.1069% 3.2324% 4.3202%
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 4.3202 percent be multiplied by the
proportion of all costs other than PC&B to total costs of OTC monograph
drug activities (see section 744M(c)(1)(C)(ii) of the FD&C Act).
Because 56.4429 percent was obligated for PC&B (as shown in table 2),
43.5571 percent is the portion of costs other than PC&B (100 percent-
56.4429 percent = 43.5571 percent). The non-payroll adjustment is
4.3202 percent x 43.5571 percent, or 1.8818 percent.
Next, we add the payroll adjustment (3.0758 percent) to the non-
payroll adjustment (1.8818 percent), for a total inflation adjustment
of 4.9576 percent (rounded) for FY 2026.
IV. OMOR Fee Calculations
Under section 744M(a)(2)(A) of the FD&C Act, each person that
submits a qualifying OMOR shall be subject to a fee for an OMOR. The
amount of such fee shall be:
(1) For a Tier 1 OMOR, $500,000, adjusted for inflation for the FY
(see section 744M(a)(2)(A)(i) of the FD&C Act); and
(2) For a Tier 2 OMOR, $100,000, adjusted for inflation for the FY
(see section 744M(a)(2)(A)(ii) of the FD&C Act).
In addition, under section 744M(c)(1)(B)(i) of the FD&C Act and for
purposes of section 744M(a)(2) of the FD&C Act, the inflation
adjustment for the FY 2026 OMOR fee shall be equal to the product of:
(1) the fee for FY 2025 under section 744M(a)(2) of the FD&C (as in
effect during OMUFA I); and
(2) the inflation adjustment percentage under subparagraph (C) of
section 744M(c)(1) of the FD&C Act.
Therefore, for FY 2026, the base of OMOR fees taken from the
preceding FY (i.e., FY 2025) are: Tier 1: $559,777 and Tier 2:
$111,955. The FY 2026 inflation adjustment percentage is: 4.9576
percent.
V. Fee Schedule for FY 2026
The fee rates for FY 2026 are displayed in Table 4.
Table 4--Fee Schedule for FY 2026
------------------------------------------------------------------------
FY 2026
Fee category fee rates
------------------------------------------------------------------------
OMOR:
Tier 1.................................................... $587,529
Tier 2.................................................... 117,505
------------------------------------------------------------------------
VI. Fee Payment Options and Procedures
The new OMOR fee rates are for the period from October 1, 2025,
through September 30, 2026. To pay the OMOR fees, complete an OTC
Monograph User Fee Cover Sheet, available at: <a href="https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp">https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp</a>, and generate a user fee identification (ID)
number. Payment must be made in U.S. currency drawn on a U.S. bank by
electronic
[[Page 60721]]
check or wire transfer, payable to the order of the Food and Drug
Administration. The preferred payment method is online using electronic
check (Automated Clearing House (ACH) also known as eCheck). FDA has
partnered with the U.S. Department of the Treasury to utilize <a href="http://Pay.gov">Pay.gov</a>,
a web-based payment application, for online electronic payment. The
<a href="http://Pay.gov">Pay.gov</a> feature is available on the FDA website after completing the
OTC Monograph User Fee Cover Sheet and generating the user fee ID
number.
Secure electronic payments can be submitted using the User Fees
Payment Portal at <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>. (Note: Only full
payments are accepted; no partial payments can be made online). Once an
invoice is located, ``Pay Now'' should be selected to be redirected to
<a href="http://Pay.gov">Pay.gov</a>. Electronic payment options are based on the balance due.\5\
---------------------------------------------------------------------------
\5\ Payment by credit card is available for balances that are
less than $25,000 (Discover, VISA, MasterCard, American Express). If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S. bank accounts as well as U.S.
credit cards.
---------------------------------------------------------------------------
For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied,
which could result in FDA not filing an OMOR request, or other
consequences of nonpayment. The originating financial institution may
charge a wire transfer fee. Include applicable wire transfer fees with
payment to ensure fees are fully paid. Questions about wire transfer
fees should be addressed to the financial institution. The following
account information should be used to send payments by wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33.
FDA's tax identification number is 53-0196965.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23852 Filed 12-23-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 29, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.